AIDS Community Research Initiative of America (ACRIA) - Summer 2002
Jeff Gustavson

As more people with HIV live longer these days, liver disease is becoming a larger health threat than the usual opportunistic infections. In the emotionally charged world of organ transplantation, giving livers to HIV-positive people has been controversial.

Michelle Roland, MD, an Assistant Professor of Medicine in the UCSF Positive Health Program at San Francisco General Hospital, notes that before people with HIV began doing so much better, "it was felt that it didn't make sense to take a very scarce resource and allocate that resource to a patient population that wasn't likely to benefit from it for very long. As fewer people [in the US] die from traditionally defined opportunistic infections, they're developing the complications of hepatitis B and C, including end stage organ failure. There's an increasing need to consider the safety and efficacy of organ transplants."

Also, according to Dr. Roland, since HIV itself "is a disease of immunosuppression, there has been substantial concern that the post transplant immunosuppression might cause acceleration of HIV disease progression." Nevertheless, some immunologists wonder if suppressing the generalized activation of the immune system might even be beneficial to people with HIV, although no study has yet shown this.

Dr. Roland sees many patients with end stage liver disease. She says, "Transplant is not the right option for a lot of people. It's a very personal decision. They have to ask themselves, 'Do I want to step into this high-tech medical intervention with all these potential complications and have the possibility of the end of my life being in an intensive care unit?'"

Another big question for transplants in HIV-positive people is how to pay. Some third party payers have declared that they need proof that transplants work for people with HIV, which is a Catch 22 - you can't prove it if no transplants are done because no one will pay. A pilot study was started at UCSF called the Migden HIV Transplant Initiative when State Assemblywoman Carole Migden and AIDS activist Jeff Getty were able to secure a large California state appropriation. "At the same time," Dr. Roland says, "we pulled together a group of transplant centers across the country to develop a common protocol to learn as much as we could as fast as we could while sharing clinical experiences along the way." One goal of the study is to develop clinical practice guidelines. An investigator-initiated grant application was submitted to the National Institutes of Health. The expense of the clinical costs (not the surgical costs) will likely have to be borne by insurers or the patients themselves.

At the 9th Conference on Retroviruses and Opportunistic Infections in February, Dr. Roland presented data on 41 HIV-positive transplant recipients who would have been eligible for the UCSF protocol (no history of opportunistic infections and fully suppressed or suppressible virus). Half of them had received livers and the other half kidneys. Half of these patients had a follow up of at least 279 days and were compared with one-year survival data collected by the organization that monitors transplants. The HIV-positive recipients fared almost as well as people who were HIV-negative. HIV viral load remained relatively controlled and there were only two opportunistic infections. A 15-year-old boy had CMV esophagitis and hepatitis C recurrence with a relatively high T-cell count and died. Another recipient had Candida esophagitis that responded very quickly to treatment.

However, eight patients who did not meet the eligibility criteria for the protocol didn't fare so well. There were two cases of PML and one case of MAC. This is the justification for the rather strict entry requirements for the study. Dr. Roland will give an update on how people are doing at the International AIDS Conference in Barcelona in July.

There are plans to open up the protocol gradually to people with a history of opportunistic infections and, possibly, detectable viral load, once safety and efficacy have been demonstrated in the more conservatively chosen patients.

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